patients phase i clinical trials – secured multi site model for key populations recruitment

PATIENTS PHASE I CLINICAL TRIALS –

SECURED MULTI SITE MODEL FOR KEY

POPULATIONS RECRUITMENT

Dr. Istvan Udvaros

Medical and Project Director Oncology

SGS Life Science Services

SAFETY & EFFICACY CLINICAL TRIAL SOLUTIONS SGS Life Science Services Biopharm Day Seminar – Antwerp, October 29, 2015

2 SGS LIFE SCIENCE SERVICES BIOPHARMA DAY – OCTOBER, 29 2015

PHASE 1 TRIALS IN EU 2015 (OPEN,

INTERVENTIONAL) SOURCE WWW.CLINICALTRIALS.GOV

All With patients


PATIENT TRIAL PHASE I MARKET IN EU 2015

Belgium (47)

Oncology 72 %

Organ impairment 4 %

Reum/Immun 5 %

Neurology 6 %

France (114)

Oncology 79 % !!!!

Neurology 7 %

UK (131)

Oncology 58 %

Cardiovascular 9 %

Pulmonology 6 %

Reum/Immun 6%

Germany (99)

Oncology 63 %

Neurology 8 %

Reum/Immun 8 %

Metabolic 7%

Poland/Hun (17)

Oncology 50%

Reum/Immun 29%

Key EP EU indications:

1. Oncology is TOP !!!

2. Immunology

3. Elderly population diseases


FROM LEAD COMPOUND TO PROOF OF

CONCEPT – THE SPONSOR PERSPECTIVE


THE CRO PERSPECTIVE

Large number of request from stand alone to complete drug

development and service packages

Wide range of therapeutical compounds large and small target molecules

immune therapies, vaccines, vectors, adjuvants

generics, biosimilars

Various other compounds Supportive drugs: myelosuppression, anaemia, pain, cachexia, etc

Others: diagnostics, devices, etc

Complex or special study designs

Strict inclusion/exclusion criterias, short timelines,

pressure on costs

Competitive trials

Demanding patient populations


SOLUTIONS TO HANDLE COMPLEXITY

Professional environment dedicated to Early Phase trials

Infrastructure

• Phase I Unit (CPU)

• Satellite Sites within high patient access institutions

• External sites

Resources

• Clinical teams (medics, nurses, lab technicians)

• Site and study coordinators, project managers

• Feasibility, regulatory, functional services

Proper experience both in development phase and therapeutic indication (clinical and pharmacological)

Adaptive, flexible, service oriented attitude to find optimal solutions

Networking skills (KOLs, sites, referrals, patient groups)

Strong vendor management

Regulatory intelligence


PATIENT ACCESS SOLUTIONS

Large Academic centers

Competitive trials

Innovative value expected to be

high

SMOs with Early Phase

experience

Limited selection

CPU internal efforts

Efficiency issues

External/satellite sites in proximity

to CPU

Limitations in recruitment could still happen

Inclusion of additional

geographic areas

Business environment (regulatory, contracting,

etc..)

Quality and logistical aspects

Cost/benefit estimations


SGS CLINICAL PHARMACOLOGY UNIT

IN PATIENT TRIALS

Largest CPU in Belgium designed for HV and special

population trials

Center of EP excellence

Special infrastructure (pharmacy, viral challenge unit)

88 beds, high number of subject visits on a daily basis

Logistics and operations developed for mass workload

Dedicated SMO group to support recruitment in PTs

Database development

Advertising campaigns

Networking with referrals and patient associations

Solid access to patients in common chronic medical conditions

Renal impairment

Chronic respiratory diseases (COPD, asthma) etc..


OUR SATELLITE /PATIENT SITE MODEL

Cooperation with hospitals to create/facilitate Phase I patient

units

MSA agreement

Direct access to patient pools of selected indications via close

in-house cooperation with specialists

Partnership and support

Operational excellence and complete control over clinical

execution

SGS SOP package for proper know-how and transparency

SGS key medical staff to ensure quality in operation

“Extension of CPU”

Access to CPU capabilities, know-how, staff, services

Pan European Model

Belgium network (AZSM, Jesse)

CEE network (Hungary, Poland, Czech)


SGS SATELLITE / PATIENT CENTERS

BELGIUM / HUNGARY

In operation: AZ St Maarten, Mechelen, Belgium

8 beds

Access to pharmacy, lab, imaging, emergency, catering, ...

Physicians collaborate as Sub-I or PI

Study conducted by SGS staff

Therapeutic areas

• Nephrology, Hepatology, GI, Immunology, Oncology, Pneumonology,

Endocrinology, Dermatology, Neurology, Neuro surgery, Vascular surgery

CEE Pilot : National Central Military Hospital, Budapest, Hungary

5 beds (linked to Department of Oncology)

SGS employed medical team (CRP,SN) present, SGS SOPs

Coordinating site in local networking (access to further sites)

Transparent regulatory environment

Developed business service background

Therapeutic areas

• Oncology, Nephrology, Neurology, Rheumatology, Dermatology, etc…


SUBCONTRACTED PARTNER MODEL

Select and subcontract recruitment expert external CROs

As additional or alternative solution

Flexibility to increase access to patients

Added value: expertise in special indication or in geographic

location where recruitment potential is beneficial enough

Proper proactive control is key in success

Partnership type long term cooperation is preferred


TAKE HOME MESSAGES

Patient trials in EP are significant and further short and middle

term increase is expected

There is a very colorful palette of EP trials – even the best

single operational model will not be able to manage them

alone

Flexible/adaptive and service orientated attitude is needed to

find optimal solutions

Building up some models – like the satellite centre one in our

case – needs strategic thinking and significant investments but

can effectively fulfill sponsor demands


ADDED VALUE IN CLINICAL TRIALS


EXPERIENCE & THERAPEUTIC AREA


FACILITIES


PATIENTS RECRUITMENT


SINT MARTEEN & SGS SUPPORTING PHYSICIANS


Life Science Services Istvan Udvaros MD MSc

Medical Director Clinical Research

Project Director Oncology

SGS Belgium NV Phone: + 32 (0)15 28 30 46

Generaal De Wittelaan 19A, Fax: + 32 (0)15 27 32 50

B-2800 E-mail : [email protected]

Mechelen

Belgium Web : www.sgs.com/lifescience

THANK YOU FOR YOUR ATTENTION

+ 41 22 739 9548

+ 1 866 SGS 5003

+ 65 637 90 111

+ 33 1 53 78 18 79

+ 1 877 677 2667

+ 33 1 41 24 87 87


QUESTIONS ?

patients phase i clinical trials – secured multi site model for key populations recruitment

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